Nicolab’s Post

A deadline for compliance with the EU Medical Device Regulation (#MDR) is fast approaching. By 𝐒𝐞𝐩𝐭𝐞𝐦𝐛𝐞𝐫 𝟮𝟲, 𝟮𝟬𝟮𝟰, you must have a signed written agreement with a #NotifiedBody for the conformity assessment of your devices. This step is crucial to ensure that medical devices meet the new, stricter MDR standards, enhancing safety and efficacy for patients across the EU. Note that this deadline is only relevant for legacy device manufacturers. It was part of a proposal by the European Commission in 2023. If you want to learn more about the other deadlines set in this proposal click the link to our article: https://lnkd.in/eBw9Vv92

Irema Ireland was one of the first European facemask manufacturers to become MDR compliant and has maintained exceptionally high standards in face mask production. If you want to learn more about MDR ( Medical Device Regulation), here is a quick read!

In a recent webinar, Ibim Tariah and Gregory Jacobson discussed the regulatory considerations associated with notified body opinion in accordance with Article 117 of the MDR for products incorporating a nonreusable medical device. 📺 Now available on YouTube: https://bit.ly/4cLzALb #MedicalDevices #MDR #MDD #SGSNorthAmerica

🔴 Availability is everything, especially when it comes to life-saving treatments. It's one of the primary reasons that medical device companies should already be preparing for the European Medical Device Regulation (EU MDR). Failure to comply could mean more devices being removed from the market, and more patients without treatment. Don't take a "wait and see" approach to EU MDR – your device's availability could be at stake! Dive into our blog to get all the definitions, deadlines, and device classifications you'll need to navigate the evolving medical device landscape with ease: https://bit.ly/3UiFltv

Irema Ireland was one of the first European facemask manufacturers to become MDR compliant and has maintained exceptionally high standards in face mask production. If you want to learn more about MDR ( Medical Device Regulation), here is a quick read!

If you are frustrated with the MDR and your options for entering the European Medical Device market, reach out to learn more about new developments at TÜV SÜD and what we can do to help! #MedicalDevices #MDR

📅 Upcoming 26 May 2024 Deadline Reminder! As we approach the crucial deadline of May 26, 2024, under the Medical Device Regulation (MDR), manufacturers are reminded of the significant requirement to sign a written agreement with a Notified Body (NB) and transfer appropriate surveillance to an MDR NB. Are you ready? #trinitymconsulting #globalconsulting #mdr #regulatoryconsulting

If you still have medical devices under the superseded EU Medical Device Directive (MDD), you should transition to the Medical Device Regulation (MDR) as soon as possible. 👉 By May 26, 2024 You should lodge an application with us, Notified Body 1639, and have an MDR QMS in place. 👉 By September 26, 2024 You should sign a written agreement with us. This means you can legally keep your medical devices in the EU market. Learn more: https://bit.ly/3CcE1hO. #MDR #MDD #MedicalDevices #Certification

If you still have medical devices under the superseded EU Medical Device Directive (MDD), you should transition to the Medical Device Regulation (MDR) as soon as possible. 👉 By May 26, 2024 You should lodge an application with us, Notified Body 1639, and have an MDR QMS in place. 👉 By September 26, 2024 You should sign a written agreement with us. This means you can legally keep your medical devices in the EU market. Learn more: https://bit.ly/3CcE1hO. #MDR #MDD #MedicalDevices #Certification

📢 Attention Medical Device Manufacturers: Share Your Feedback on MDR/IVDR! The European Commission is seeking input from the medical device industry regarding the MDR/IVDR framework. This is an opportunity to share your experiences and challenges as one of the key stakeholders and contribute to the development of a better regulatory framework. 💡 Why is your feedback important? Your insights can help shape improvements to the framework, ensuring a more efficient and balanced system for all stakeholders. 👉 Take action now and make your voice heard: https://brnw.ch/21wPy8F #MDR #IVDR #Regulations #NotifiedBody #MedicalDevices #Feedback